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Pegvisomant And Sandostatin LAR Combination Study

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NCT00068029

Last updated on April 2, 2020
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Los Angeles, California, 90048 United States
See other locations
Contact
1-800-718-1021
[email protected]
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Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Acromegaly
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Diagnosis of acromegaly

- Received previous radiation and/or surgical treatment for their GH (Growth Hormone)
producing pituitary adenoma and have required medical therapy due to failure to
normalize GH (Growth Hormone) and/or IGF-I as a result of their primary treatment

- Patients that been receiving Sandostatin LAR for a minimum of 6 months prior to
enrollment

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Presence of other conditions that may result in abnormal GH (Growth Hormone) and/or
IGF-I concentrations

- Patients on current medical therapy other than Sandostatin LAR

- AST/ALT >= 3xULN (upper limits of normal)

- Pituitary adenoma within 3mm of optic chiasm confirmed by recent MRI

- Visual field defects (except post-surgical stable residual defects)

- Unable to self administer drug

- Radiotherapy within 12 months of entering the study

NCT00068029
Pfizer
Completed
Pegvisomant And Sandostatin LAR Combination Study

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Pfizer Clinical Trials Contact Center

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[email protected]

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Descriptive Information
Brief Title  ICMJE Pegvisomant And Sandostatin LAR Combination Study
Official Title  ICMJE A Randomized, Parallel Group, Three-Arm Study To Evaluate Treatment With A Combination Of Pegvisomant Plus Sandostatin Lar, Pegvisomant (Alone), And Sandostatin Lar (Alone) In Patients With Acromegaly
Brief Summary The purpose of this study is to compare the safety and tolerability of combination therapy with Sandostatin LAR plus Pegvisomant to that of Sandostatin LAR alone or Pegvisomant alone.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acromegaly
Intervention  ICMJE
  • Drug: Pegvisomant/ Sandostatin LAR
  • Drug: Sandostatin LAR
  • Drug: Pegvisomant
Study Arms  ICMJE Not Provided
Publications * Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: August 30, 2005) 		75
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE May 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of acromegaly
  • Received previous radiation and/or surgical treatment for their GH (Growth Hormone) producing pituitary adenoma and have required medical therapy due to failure to normalize GH (Growth Hormone) and/or IGF-I as a result of their primary treatment
  • Patients that been receiving Sandostatin LAR for a minimum of 6 months prior to enrollment

Exclusion Criteria:

  • Presence of other conditions that may result in abnormal GH (Growth Hormone) and/or IGF-I concentrations
  • Patients on current medical therapy other than Sandostatin LAR
  • AST/ALT >= 3xULN (upper limits of normal)
  • Pituitary adenoma within 3mm of optic chiasm confirmed by recent MRI
  • Visual field defects (except post-surgical stable residual defects)
  • Unable to self administer drug
  • Radiotherapy within 12 months of entering the study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Brazil,   Canada,   France,   Germany,   Italy,   Mexico,   Netherlands,   Norway,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00068029
Other Study ID Numbers  ICMJE PEGA-0435-005
A6291006
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date April 2008

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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